AGGAMIN PHARMACEUTICALS, LLC — Department of Health and Human Services SBIR Phase II: NICHD

Description

DESCRIPTION provided by applicant Preeclampsia PE is a pregnancy induced hypertensive disorder without an effective treatment The goal of this project is to produce a novel apheresis therapy for treatment of PE PE is the leading cause of pregnancy related mortality and morbidity in the US affecting over pregnant women and newborns annually at a significant cost to the healthcare system PE is characterized by an onset of hypertension and proteinuria and can lead to serious complications including eclampsia seizure and HELLP syndrome associated with organ failure and death Interventions include magnesium sulfate to prevent seizure and antihypertensives to reduce blood pressure but they do not target the underlying pathogenesis of the disease One potential cause of PE is an imbalance of angiogenic factors resulting from overexpression of anti angiogenic factors soluble VEGF receptor sVEGFR and soluble endoglin sEng Excess levels of sVEGFR and sEng correlate with disease severity and poor clinical outcome The product of this SBIR will be an ex vivo immunoadsorption apheresis device PE Device to reduce sVEGFR and sEng to normal pregnancy levels and prolong pregnancy without adverse maternal or fetal effects Due to the nature of the high risk patient population and to increase safety Aggaminandapos s PE Device therapy is extracorporeal and will not introduce exogenous agents to maternal or fetal circulation The long term goal is to commercialize PE Device therapy to improve health outcomes by reducing maternal symptoms and extending fetal gestation Our SBIR Phase I studies showed a scale down device containing both VEGFR and Eng antibodies removed andgt of sVEGFR and sEng from plasma For SBIR Phase II we now propose to produce a full scale prototype PE device capable of reducing sVEGFR and sEng efficiently from plasma in vitro and to determine the range of processed blood volumes needed for safe reduction of endogenous sVEGFR and sEng in an animal model After Phase II Aggamin will initiate cGMP manufacturing of the PE Devices and plan for a clinical trial PE affects of all pregnancies and disease incidence is rising as risk factors such as obesity diabetes and maternal age at pregnancy increase PE patients also face lifelong consequences as they are at higher risk for developing cardiovascular diseases and stroke The market for Aggaminandapos s treatment for severe PE cases is estimated at patients annually in the US and patients worldwide and could later include PE cases in which symptoms appear at andgt weeks The total market for Aggaminandapos s therapeutic product to treat severe PE cases in the U S is estimated at $ billion Reimbursement rates for adsorption apheresis can be justified by reduction or elimination of NICU costs and improved health outcomes If proven safe and effective the PE Device therapy has the potential to alter the clinical practice for the treatment of PE and have a significant impact on maternal and fetal health PUBLIC HEALTH RELEVANCE In this SBIR Phase II Aggamin plans to develop an ex vivo adsorption device PE Device to treat preeclampsia patients Preeclampsia is a pregnancy induced hypertensive disease associated with high maternal and fetal deaths There is no effective treatment except for premature delivery which jeopardizes the fetus Aggaminandapos s PE Device therapy is expected to reverse maternal symptoms prolong pregnancy and improve maternal and fetal health